Biceps Repair Device

ABSTRACT

Methods and devices are provided for anchoring a ligament or tendon to bone. In general, various inserter tools are provided for simultaneously delivering an expandable sheath and an expander into bone. With both components of the implant mounted on the same tool, the sheath and a ligament can be advanced into a bone hole and the expander, which trails behind the sheath during delivery of the sheath, can be advanced into the sheath to expand the sheath and anchor the sheath and ligament within the bone hole.

FIELD

Surgical devices and methods are provided for anchoring tissue to bone,and more particularly surgical implants, delivery tools, and methods areprovided for securing a biceps tendon to the humerus.

BACKGROUND

Disorders of the long head of the biceps tendon are a common source ofshoulder pain and may occur in association with other diagnoses such asrotator cuff tears, superior labrum anterior posterior tears,impingement syndrome and capsular injuries, or may be present as anisolated source of shoulder pain. The treatment options for disorders ofthe long head of the biceps (LHB) continue to evolve and can include LHBtenodesis. In a tenodesis procedure, a suture is passed through the baseof the LHB to locate the LHB in the subacromial space and to provideproximal control during the dissection. Once the suture is placed, theLHB is cut near the glenoid attachment. A sizer can be used to measurethe tendon size and to thereby determine the appropriately sized bonescrew. Once the screw is selected, a bone hole is drilled and a tendonfork is then used to push the tendon down into the bone hole. A bonescrew is then delivered into the bone hole to anchor the tendon withinthe bone hole.

While current procedures can provide an effective means for anchoring atendon to bone, they can suffer from several drawbacks. For example,current procedures require the use of numerous tools, which can lead toa prolonged procedure and increased costs. The use of a screw can alsoincrease the risk of damage to the tendon, as rotation of the screw intothe bone hole can tear or sever through the tendon. Moreover, it can bedifficult to maintain the desired tension on the tendon while the screwis being implanted, as the tendon can become misaligned and or can slipduring insertion of the screw. Any tension applied to the tendon duringinsertion of the anchor can also cause the anchor to back-out of thebone hole.

Accordingly, there remains a need for improved methods and devices foranchoring tissue to bone, and in particular for performing a bicepstenodesis.

SUMMARY

Various implants, tools and methods are provided for attaching a tendonto bone. In one embodiment, a bone anchor inserter tool is providedhaving an outer shaft and an inner shaft. The outer shaft can havehaving proximal and distal ends and an inner lumen extending at leastpartially therethrough, the distal end having first and second prongsextending distally therefrom. The inner shaft can extend through theinner lumen of the outer shaft and can be non-slidably fixed to theouter shaft, the inner shaft having a distal-most end terminating at alocation distal to the distal end of the outer shaft and proximal to adistal-most end of the first and second prongs.

The inner shaft can have a variety of configurations, and in oneembodiment the inner shaft is freely rotatable relative to the outershaft. A distal portion of the inner shaft can be in the form of a drivetip that is configured to extend into a lumen in an implant and to applya rotational force to the implant. In another embodiment, the innershaft is non-rotatably fixed to the outer shaft.

The outer shaft can have a variety of configurations, and in oneembodiment the distal end of the outer shaft includes viewing windowsformed in opposed sidewalls thereof. The first and second prongsextending distally from the distal end of the outer shaft can also havea variety of configurations and in some aspects the first and secondprongs can be elongate wires, each elongate wire having a proximal endthat is fixedly disposed within a bore formed in the distal end of theouter shaft. In some aspects, the first and second prongs compriseelongate members formed from a super elastic or shape memory material.

The bone anchor inserter tool can also include various other components,such as a driver shaft having an inner lumen extending therethrough, thedriver shaft being configured to be slidably and rotatably disposedbetween the outer shaft and the inner shaft. In some aspects, the drivershaft can include a drive tip at a distal end thereof that is configuredto extend into a lumen in an implant and to apply a rotational force tothe implant.

In another embodiment, a bone anchor and delivery system is providedthat includes an anchor assembly and a delivery tool. The anchorassembly can include an expandable sheath having opposed slots formedtherein and an inner lumen extending at least partially therethrough andan expander configured to be received within the inner lumen of thesheath to cause the sheath to expand outward, the expander having aninner lumen extending therethrough. The delivery tool can include anouter shaft having first and second prongs extending distally from adistal end thereof and configured to extend along opposed slots formedin the sheath, and an inner shaft extending through and mated to theouter shaft such that the inner shaft is prevented from sliding axiallyrelative to the outer shaft. In the bone anchor and delivery system, theprongs of the outer shaft can be positioned to extend along the opposedslots in the sheath and the expander can be disposed within the outershaft proximal of the sheath, the inner shaft can extend through theinner lumen in the expander and a distal end of the inner shaft can abutagainst a distal inner surface of the sheath such that the inner shaftcan apply a force to the sheath to advance the sheath into a bone hole.

The inner shaft can have a variety of configurations, and in oneembodiment the inner shaft is freely rotatable relative to the outershaft. The inner shaft can include a drive tip that is configured toextend into a drive recess formed in the expander for driving theexpander into the sheath. In another embodiment, the inner shaft can benon-rotatably fixed to the outer shaft.

The bone anchor and delivery system can also include various othercomponents, such as a driver shaft having an inner lumen extendingtherethrough, the driver shaft being slidably and rotatably disposedwithin the outer shaft, and the inner shaft being disposed through theinner lumen of the driver shaft. The driver shaft can include a drivetip at a distal end thereof that is configured to extend into a driverecess in the expander for driving the expander into the sheath.

In yet another embodiment, a method of implanting an anchor in bone isprovided that includes positioning a sheath coupled to a distal end ofan outer shaft of an inserter tool adjacent to a ligament to be advancedinto a bone hole, and manipulating the inserter tool to advance thesheath and the ligament into the bone hole, the inserter tool having aninner shaft extending through the outer shaft, the inner shaft applyinga force to a distal end of the sheath to advance the sheath and theligament into the bone hole. The method also includes manipulating theinserter tool to advance an expander disposed over the inner shaft intothe sheath, the expander causing the sheath to expand outward and engagethe bone hole to thereby anchor the ligament within the bone hole.

The method can include manipulating the inserter tool to advance theexpander into the sheath comprises rotating the inner shaft relative tothe outer shaft to cause the expander to be threaded into the sheath.The inner shaft can be prevented from translating relative to the outershaft. In some embodiments, the expander is at least partially threadedinto the sheath when the sheath is advanced into the bone hole. In someembodiments, manipulating the inserter tool to advance the expander intothe sheath includes axially translating a driver shaft through the outershaft and over the inner shaft.

In yet further embodiment, a method for anchoring tissue to bone isprovided that can include manipulating an inserter tool to advance asheath coupled to a distal end of the inserter tool and to advance atendon positioned around the sheath into a bone hole. The inserter toolcan have a handle with a drive shaft extending distally from the handle,and an expander positioned proximal of the sheath and disposed on adistal end of the drive shaft such that the expander trails the sheathas the sheath and the tendon are advanced into the bone hole. The methodcan further include rotating the handle of the inserter tool to rotatethe drive shaft and thereby cause the expander to rotate, whereinthreads on the expander engage corresponding threads formed within thesheath to advance the expander distally into the sheath. The expandercan cause the sheath to expand outward to thereby anchor the sheath andthe tendon within the bone hole.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments described above will be more fully understood from thefollowing detailed description taken in conjunction with theaccompanying drawings. The drawings are not intended to be drawn toscale. For purposes of clarity, not every component may be labeled inevery drawing. In the drawings:

FIG. 1A is a perspective view of one embodiment of a biceps tenodesissystem having a sheath, an expander, and an inserter tool including anouter shaft and an inner shaft;

FIG. 1B is an exploded side perspective view of the biceps tenodesissystem of FIG. 1A;

FIG. 2A is a side perspective view of the sheath of FIG. 1A;

FIG. 2B is another side perspective view of the sheath of FIG. 1A;

FIG. 2C is another perspective view of the sheath of FIG. 1A;

FIG. 3A is a side perspective view of the expander of FIG. 1A;

FIG. 3B is a side perspective view of another embodiment of an expander;

FIG. 3C is a side perspective view of yet another embodiment of anexpander;

FIG. 4A is a side perspective view of the outer shaft of the insertertool of FIG. 1A;

FIG. 4B is a cross-sectional view of the outer shaft of FIG. 4A;

FIG. 5A is a side perspective view of the inner shaft of the insertertool of FIG. 1A;

FIG. 5B is a cross-sectional view of a proximal portion of the innershaft of FIG. 5A;

FIG. 6A is a side view of a distal portion of the system of FIG. 1A;

FIG. 6B is a side perspective view of a distal portion of the system ofFIG. 1A;

FIG. 6C is a cross-sectional view of a distal portion of the system ofFIG. 1A;

FIG. 6D is a side view of a distal portion of the system of FIG. 1A,shown in use inserting a tendon into a bone hole in bone;

FIG. 7A is a perspective view of another embodiment of a bicepstenodesis system having a sheath, an expander, and an inserter toolincluding an outer shaft, an inner shaft, and a driver shaft disposedbetween the outer and inner shafts;

FIG. 7B is an exploded side perspective view of the biceps tenodesissystem of FIG. 7A;

FIG. 7C is a side perspective view of the outer shaft of the insertertool of the system of FIG. 7A;

FIG. 7D is a side perspective view of the outer shaft, the driver shaft,and the inner shaft of the inserter tool of the system of FIG. 7A;

FIG. 7E is a side perspective view of the driver shaft and the innershaft of the inserter tool of the system of FIG. 7A;

FIG. 8A is a side perspective view of a distal portion of the insertertool of the system of FIG. 7A;

FIG. 8B is a side perspective view of a distal portion of the insertertool of the system of FIG. 7A coupled to the expander;

FIG. 8C is a cross-sectional view of a distal portion of the system ofFIG. 7A, shown before the expander is advanced into the sheath;

FIG. 8D is a side perspective view of a distal portion of the insertertool of the system of FIG. 7A coupled to the expander and the sheath;

FIG. 9A is a cross-sectional view of a distal portion of the system ofFIG. 7A;

FIG. 9B is a side view of a distal portion of the system of FIG. 7A,shown as being used to insert a tendon into a bone hole in bone.

FIG. 10A is a side perspective side view of another embodiment of aninserter tool having a shaft for simultaneously delivering a sheath andan expander into a bone hole; and

FIG. 10B is a cross-sectional view of a distal portion of the tool,sheath, and expander of FIG. 10A.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

In general, methods and devices are provided for anchoring a ligament ortendon to bone. In an exemplary embodiment, the methods and devices areused to perform a biceps tenodesis surgery, however, a person skilled inthe art will appreciate that the devices and methods can be used invarious procedures and for anchoring any tissue to bone. In exemplaryembodiments, various inserter tools are provided for delivering a boneanchor having both an expandable sheath and an expander into a bone holeto anchor a tendon or other issue within the bone hole. The describedsystem is configured as a so-called “all-in-one” device that can be usedto both insert the sheath into a bone hole and advance the expander intothe sheath to expand the sheath outward and thereby anchor a tendon inthe bone hole. Thus, separate tools for inserting the sheath and thendriving the expander thereto are not required. Accordingly, the systemhas a reduced number of components, which can reduce the number of steps(and therefore, amount of time) required to perform a biceps tenodesisprocedure. The entire attachment preparation procedure can bestraightforward and requires a surgeon to take only a few quick steps toaffix the implant structure including the sheath and the expander to thebone. Also, the surgery can be performed with minimal risk of injuringto the tendon. The sheath can be anchored without rotating the sheath,which can eliminate or reduce a possibility of undesirable twisting ofthe tendon. In addition, the described techniques can help saveoperating room costs.

FIGS. 1A and 1B illustrate one embodiment of a biceps tenodesis system100 including an inserter or delivery tool 102 that includes an outershaft 400, an inner shaft 500, and a handle assembly 104 coupled toproximal ends of the outer and inner shafts 400, 500. By way of exampleonly, the tool is shown coupled to an expandable sheath 200 and anexpander 300. As shown in FIG. 1A, in the assembled configuration, theexpandable sheath 200, expander 300, and outer and inner shafts 400, 500are disposed so that their longitudinal axis can coincide. The insertertool 102 is configured to be coupled to both the expander 300 and thesheath 200, and to apply a force to a distal end of the sheath 200 andthus advance the sheath 200 with a tendon disposed therearound into abone hole. The expander 300 is configured to be received within a lumenextending at least partially through the expandable sheath 200 tothereby expand the sheath 200. The inserter tool 102 also causes theexpander 300 to advance into the lumen of the sheath 200 to expand thesheath 200. In this way, the system 100 is used as an “all-in-one”device configured to both deliver the tendon or ligament into the bonehole and lock the sheath 200 within the bone hole.

FIGS. 2A-2C illustrate the implantable sheath 200 of FIGS. 1A and 1B inmore detail. In general, the sheath is configured to seat a tendontherearound, and to receive the expander 300 therein which is effectiveto cause the sheath to expand into bone to anchor the tendon within abone hole. The sheath can be formed from any bio-compatible material,and, in some embodiments, it can be bio-absorbable. The shape andconfiguration of the sheath can vary. By way of example, the sheath 200can be configured as described at least in U.S. patent application Ser.No. 14/610,602, entitled “Biceps Tenodesis Implants and Delivery Tools,”filed Jan. 30, 2015, the contents of which are incorporated herein byreference in their entirety.

In general, the sheath 200 has a generally elongate cylindrical shape,with a circular or oval cross-sectional geometry. The sheath 200 isconfigured to move from a collapsed position to an expanded position andhas a proximal end 200 p and a distal end 200 d, as shown in FIG. 2A.The sheath 200 can be a split sheath, with first and second sidewalls202 a, 202 b that are connected at the distal end 200 d and that areseparated by first and second elongated slots 204 a, 204 b extendingtherebetween. The elongate slots 204 a, 204 b can have any suitableconfiguration. For example, in some embodiments, as shown in FIG. 2A,the slots can have a distal portion 205 d having a width that is lessthan a width at a proximal portion 205 p. As shown, the sheath 200 hasan inner lumen 206 defined by the inner surfaces of the first and secondsidewalls 202 a, 202 b and extending at least partially through thesheath 200.

The distal end 200 d of the sheath 200 can be solid and closed. In theillustrated embodiment, both the sheath 200 and the expander 300 areconfigured to be axially aligned and disposed on the same tool, and aguidewire to guide the expander into the sheath 200 may not be needed.However, in some embodiments, the guidewire can be used. In suchembodiments, an inner surface (not shown) of the distal end 200 d of thesheath 200 can include a bore formed therein that is configured toreceive a guidewire therethrough. Also, although some of the figuresshow a guidewire bore in the distal end of the sheath 200, it should beappreciated that the guidewire bore may not be necessary if theguidewire is not used.

As shown in FIG. 2C, the sheath 200 can also include a distal facingsurface that is concave or saddled to seat the tendon thereon, and aconvex proximal surface on each side wall 202 a, 202 b. The sheath 200can also include various surface features formed thereon or therein tofacilitate engagement with the bone and the expander 300. In oneembodiment, a proximal portion 208 of the sheath 200 can have ribs 210a, 210 b, 210 c, 210 d, 210 e that allow the sheath to be inserted intobone without the need to rotate the sheath, while a distal portion 212of the sheath can be free of surface features. As shown in FIGS. 2A and2C, the sheath 200 includes threads 214 formed on the internal surfaceof the sidewalls 202 a, 202 b for threadably mating with the expander300. In some embodiments, the sheath 200 can include anti-plunge tabs216 a, 216 b, 216 c, 216 d formed at the proximal end 200 p to preventover-insertion of the sheath 200 into the bone hole, and/or corticalretaining tabs 218 a, 218 b, 218 c, 218 d positioned along themid-section of the sheath 200 and configured to be positioned justbeneath the cortical bone and within cancellous bone when the sheath 200is implanted in a bone hole. The sheath 200 can additionally oralternatively include any other suitable features. For example, thesheath 200 can include anti-collapse tabs discussed in more detail inU.S. patent application Ser. No. 14/610,602. One skilled in the art willappreciate that the sheath 200 can include any other suitable features.

As indicated above, the sheath 200 is configured to receive the expander300 and is effective to expand the sheath 200 to anchor the sheath 200and tendon coupled thereto within a bone hole. As shown in FIG. 3A, inone embodiment, the expander 300 is in the form of a screw having agenerally cylindrical shape that tapers distally inward to a reduceddiameter along at least a distal portion of the length thereof. Theexpander 300 has a thread 302 formed on the outer surface thereof andextending along the entire length of the expander 300 to facilitateengagement with the sheath 200. In some embodiments, as shown in FIGS.1A and 2A-2C, at least a distal portion thread 302 a of the thread 302can be engaged, or “pre-threaded,” into the proximal end 200 p of thesheath 200 when the expander 300 and the sheath 200 are mounted on theinserter tool, as will be discussed below.

The expander 300 can be fully cannulated so that it has a bore or innerlumen 306 defined therein. The inner lumen 306 can have a shape and sizecorresponding to a shape and size of a drive feature configured to bereceived within the inner lumen 306 so as to rotate the expander 300. Inthe illustrated embodiment, the inner lumen 306 is in the form of ahexagonal drive socket configured to receive a hexagonal distal portion502 d of the inner shaft 500 to thereby allow the inner shaft 500 torotate the expander 300. The distal portion 502 d of the inner shaft 500can be inserted into the inner lumen 306 as to extend along a portion ofthe entire length of the lumen 306. A person skilled in the art willappreciate, however, that other configurations of the inner lumen 306can be used.

As further shown in FIG. 3A, the expander 300 can have a flat proximalfacing surface 308 and a flat distal facing surface 310. The proximalsurface 308 and the distal surface 310, however, can have various shapesand the shape can be configured to conform to the sheath and/or the bonesurface. A length of the expander 300 can be less than, equal to, orgreater than the length of the sheath 200.

A person skilled in the art will appreciate that the expander can have avariety of other configurations, and the expander can be configured tobe non-rotatably inserted into the sheath, rotatably inserted into thesheath, or partially non-rotatably and partially rotatably inserted intothe sheath. For example, the expander can include a proximal portionhaving threads formed thereon and a distal portion that is non-threadedand free of surface features. In use, the non-threaded distal portion ofthe expander can be non-rotatably advanced into the sheath. Once thedistal portion is fully disposed within the sheath, the expander canthen be rotated to thread the proximal portion into the sheath. Thesheath can include corresponding threads along an entire inner surfacethereof, or along on a proximal portion of the inner surface thereof,for mating with the threads on the expander.

In some embodiments, the expander can be configured to be non-rotatablyinserted into the sheath. FIG. 3B illustrates an embodiment of anexpander 320 that is configured to be non-rotatably advanced into asheath. In this embodiment, the expander 320 is in the form of a plugthat is pushed into the sheath. As shown in FIG. 3B, the expander 320has a generally cylindrical shape with a constant minor diameter D₁along a proximal portion 322 p and a distally tapered distal portion 322d. A mid-portion 322 m of the expander 320 is at least partiallydistally tapered. The illustrated expander 320 has a flat proximalfacing surface 328. A distal facing surface 330 of the expander 320 canalso be flat or it can be convex. In some embodiments, the expander 320can be generally shaped as a bullet. The proximal portion 322 p,mid-portion 322 m, and the distal portion 322 d can be free of anysurface features and can be relatively smooth. The expander 320 can befully cannulated such that it has a bore or inner lumen 326 extendingtherethrough. At least the proximal portion of the inner lumen caninclude a drive feature for allowing it to receive an inserter tool(e.g., an inner shaft of inserter tool 102) therein.

FIG. 3C illustrates another embodiment of an expander 340 that can beconfigured to be non-rotatably inserted into the sheath. As shown inFIG. 3C, the expander 340 has a generally cylindrical shape with aconstant minor diameter D₁ along a proximal portion 342 p and at leastpartially distally tapered mid- and distal portions 342 m, 342 d. Ashown, the mid-portion 342 m can be generally convex, although it shouldbe appreciated that one or more portions of the mid-portion 342 m may benot convex. The distal portion 342 d of the expander 340 is tapereddistally inward to a reduced diameter at the distal-most end of theexpander 340. The illustrated mid-portion 342 m and the distal portion342 d are free of any surface features and are relatively smooth. Theproximal portion 342 p, on the other hand, includes one or more ribs orflanges formed thereon and extending circumferentially therearound.While the proximal portion 342 p is shown having two ribs 344 a, 344 bformed thereon and spaced longitudinally apart, the expander 340 caninclude any number of ribs, or other protrusions. Each rib, as shown forthe rib 344 b, includes a flat proximal-facing surface 344 p, and anouter sidewall having a proximal constant diameter portion 344 c and adistal tapering portion 344 t. The ribs 344 a, 344 b have an outerdiameter that is greater than the minor outer diameter of the expander340. The expander 340 can have a flat proximal facing surface 348 and aflat or convex distal facing surface 350. The expander 340 can be fullycannulated for allowing it to receive an inserter tool (e.g., an innershaft of inserter tool 102) in an inner lumen or bore 346 extendingtherethrough. In use, the expander 320 can be non-rotatably advancedinto the sheath. The ribs 344 on the proximal portion 342 p can causethe sheath to expand outward thereby anchoring the sheath within thebone hole.

As indicated above, various inserter tools are provided for delivering asheath and expander into bone for anchoring a tendon to the bone.Referring back to FIGS. 1A and 1B, in the illustrated embodiment, theinserter tool 102 includes an outer shaft 400 and an inner shaft 500extending through the outer shaft 400. As further shown in FIGS. 4A and4B, the outer shaft 400 has a proximal end 400 p, a distal end 400 d,and a lumen 403 extending therethrough between the proximal and distalends 400 p, 400 d. The proximal end 400 p of the outer shaft 400 iscoupled to a distal handle 110 of the handle assembly 104, as discussedin more detail below. The distal end 400 d of the outer shaft 400 has afork 401 including first and second opposed distal prongs 404, 406extending distally therefrom. The prongs 404, 406 are configured to bepositioned along the sidewall slots in the sheath 200 to preventrotation of the sheath 200 when the inner shaft 500 is rotated to drivethe expander 300 into the sheath 200.

The distal portion 402 d of the outer shaft 400 is shown in more detailin FIGS. 6A-6D and generally has opposed arms 402A 402B with U-shapedcut-outs or window 410 formed therebetween. Each arm has a prong 404,406, extending distally therefrom. The distal portion 402 d can have anincreased diameter as compared to the remainder of the shaft 400. Also,a diameter of the outer wall of the distal portion 402 d of can varyalong a longitudinal length thereof. For example, as shown in FIGS. 6Aand 6C showing a front view of the distal portion 402 d of the outershaft 400, the distal portion 402 d can have a proximal portion 408 phaving an outer diameter that increases distally and a distal portion408 d that can have substantially constant outer diameter.

As indicated above, the distal portion 402 d can be generally arcuate orU-shaped so that it has first and second arms 402A, 402B of the “U,”each coupled to one of the prongs 404, 406. The first and second arms402A, 402B can be substantially parallel to one another and can extenddistally so as to form elongated, generally upside-down U-shaped viewingwindows 410 therebetween. It should be appreciated, however, that theviewing windows 410 can have any suitable shape, and the first andsecond arms 402A, 402B can have any suitable configuration. Additionallyor alternatively, in some embodiments, at least a portion of the outershaft 400 can be formed from a transparent material to allow viewingtherethrough. As shown in FIGS. 4A and 4B, the viewing windows 410 forma common space between the first and second arms 402A, 402B. Thus, whenthe inner shaft 500 is inserted into the outer shaft 400 and the system100 is assembled as shown in FIG. 1A and further in FIGS. 6A-6D, theviewing windows 410 allow at least a portion of the expander 300 coupledto the sheath 200 to be viewed therethrough.

The first and second opposed prongs 404, 406 of the distal fork 401 canhave any suitable configuration and they can be coupled to the outershaft 400 in any suitable manner. For example, in the embodiment of FIG.4A, the first and second prongs 404, 406 are in the form of elongatewires. However, one skilled in the art will appreciate that each of thefirst and second prongs 404, 406 can be in the form of a rod, or anyother elongate member. In the illustrated embodiment, as shown in FIG.4A, the first and second prongs 404, 406 have a generally circularcross-section, however one skilled in the art will appreciate that thefirst and second prongs 404, 406 can have a generally triangularconfiguration or any other suitable configuration.

As shown in FIG. 4A, each of the wires has its proximal end fixedlydisposed within a respective bore or slot formed in the distal portion402 d of the outer shaft 400. Thus, in FIG. 4A, a proximal end 404 p ofthe first prong 404 is shown by way of example as fixedly disposedwithin a bore 416 formed in the first arm 402A of the distal portion 402d. The bore 416 can extend through a portion of the inner wall of thearm or through the entire length of the arm. The second prong 406 iscoupled to the distal end 400 d in a similar manner. The proximal endsof the first and second prongs 404, 406 can be secured within the boresformed in the distal end 400 d by welding, adhesives, etc. However, itshould be appreciated that the prongs can be coupled to the outer shaft400 in any suitable manner. Furthermore, in some embodiments, the firstand second prongs 404, 406 can be formed integrally and/ormonolithically with the outer shaft 400.

The first and second prongs can be formed from any suitable material. Insome embodiments, the first and second prongs 404, 406 can be elongatemembers formed from a shape memory or super elastic material, such asNitinol®, nickel-titanium based alloy, or any other shape memory orsuper elastic material. Thus, the prong can retain their shape evenafter deforming forces are applied thereto.

Referring back to FIG. 1A, when the system 100 is assembled, the sheath200 is positioned at the distal end 400 d of the outer shaft 400 suchthat the first and second prongs 404, 406 of the distal fork 401 extendalong the elongate slots 204 a, 204 b in the sheath 200 and extendbeyond the distal end 200 d of the sheath 200. In this way, rotation ofthe sheath 200 during insertion of the expander into the sheath 200 isprevented. In use, as also shown in FIG. 4A, distal facing surfaces 412a, 412 b of the first and second arms 402A, 402B of the distal end 400 dof the outer shaft 400 abut against a proximal facing surface of thesheath 200.

As indicated above, the outer shaft 400 is configured to receive theinner shaft 500 therein. As shown in FIGS. 1B and 5A, the inner shaft500 can have a generally elongate cylindrical configuration. In anexemplary embodiment, as shown in FIGS. 1B and 5A, the inner shaft 500is in the form of a screw driver disposed configured to be within theinner lumen of the outer shaft 400 and having a drive tip configured toextend into the expander. In one exemplary embodiment, the inner shaft500 has a proximal end 500 p configured to mate to a proximal handle 112of the handle assembly 104, as discussed in more detail below, and adistal end 500 d configured to mate to an expander. As shown in FIGS. 1Band 5A, the inner shaft 500 includes a proximal portion 502 p, a distalportion 502 d, and a middle portion 502 m extending between the proximaland distal portions 502 p, 502 d. In the illustrated embodiment, anouter diameter of the middle portion 502 m is greater than outerdiameters of the proximal and distal portions 502 p, 502 d. The innershaft 500 can rotate relative to the outer shaft 400 such that its drivetip engaging the inner lumen of the expander causes the expander torotate and to thereby advance into the sheath, causing the sheath toexpand outward within a bone hole.

As shown in FIG. 5B, the proximal portion 502 p of the inner shaft 500has a length sufficient for the proximal portion 502 p to extend throughat least a portion of the proximal handle assembly 104. As also shown inFIG. 5B, the proximal portion 502 p slidably extends through a distalhandle 110 coupled to the outer shaft 400 and disposed distally of theproximal handle 112 coupled to the proximal portion 502 p. In this way,the inner shaft 500 maintains the proximal handle 112 at a fixed axialposition relative to the distal handle 110 such that the proximal handle112 is prevented from distal axial translation relative to the outershaft 400.

The middle portion 502 m of the inner shaft 500 extends through theouter shaft 400 such that a distal end of the middle portion 502 m abutsthe expander 300, as shown in FIG. 5B, and a proximal end of the middleportion 502 m abuts the distal handle 110 coupled to the outer shaft400.

In an exemplary embodiment, as shown in FIGS. 5A and 6C, the distalportion 502 p of the inner shaft 500 can be in the form of a drive tipfor engaging a socket in the expander. In the illustrated embodiment,the drive tip or distal portion 502 d of the inner shaft 500 has ahexagonal configuration for extending into a corresponding hexagonaldrive socket formed in the expander 300 to thereby allow the inner shaft500 to rotate the expander 300. However, one skilled in the art willappreciate that the drive tip 502 d can have any other configuration soas to fit within the inner lumen of the expander 300 and rotatablyengage the expander 300. As shown in FIG. 6C, the distal portion 502 pcan extend through the expander 300 and further distally through thesheath 200. In an exemplary embodiment, a length of the distal portion502 d of the inner shaft 500 is sufficient such that the distal end 503of the inner shaft 500 abuts the distal inner surface of the sheath 200to apply axial force to the sheath 200 to advance the sheath 200 into abone hole. Further, although in the illustrated embodiment a guidewireis not shown, in some embodiments the inner shaft 500 can furtherinclude a guidewire channel extending therethrough for allowing thesheath, the expander, and the inner and outer shafts to be slidablyadvanced over a guidewire.

When assembled, the inner shaft 500 extends through the outer shaft 400and the drive tip extends distantly beyond the distal end of the outershaft 400, terminating proximal to the prongs. In the illustratedembodiment, the inner shaft 500 is rotatably coupled to the outer shaft400 so that the inner shaft 500 can rotate, but not slide distally,within the outer shaft 400. The proximal ends of the outer and innershafts 400, 500 can be coupled to a handle assembly that allows theinner shaft 500 to rotate relative to the outer shaft 400, whilepreventing distal translation.

The handle assembly 104 configured to operate the inserter tool 102 canhave a variety of shapes and configurations. FIGS. 1A, 1B, 4A, 4B, 5A,and 5B illustrate one exemplary embodiment of a handle assembly 104 ofthe inserter tool 102 coupled to the proximal ends of the outer andinner shafts 400, 500. The handle assembly 104 can be used to applyforce to a distal end of the sheath to insert the sheath into a bonehole and to rotate the inner shaft to drive the expander into thesheath.

In the illustrated embodiment, the handle assembly 104 includes a distalhandle 110 and a proximal handle 112 that is disposed proximally of thehandle 110, as shown in FIG. 5B. The distal handle 110 is fixedlycoupled to or integrally formed on a proximal end of the outer shaft 400and the proximal handle 112 is coupled to or integrally formed on aproximal end of the inner shaft 500. As shown in FIG. 1B, in oneembodiment, the inner shaft 500 can be removably mated to the proximalhandle 112 so as to allow disassembly of the device, e.g., for cleaning.The distal handle 110 and the proximal handle 112 are shown having theshape of a disk. In the illustrated embodiment, the distal and proximalhandles 110, 112 have planar distal- and proximal-facing surfaces andhave substantially the same diameter. However, a person skilled in artwill appreciate that the distal and proximal handles 110, 112 can haveany other configuration and size to facilitate grasping. In addition,the handles 110, 112 can have various other features, such as actuators,buttons, knobs, triggers, gripping components, etc., configured tooperate the inserter tool 102.

The proximal handle 112 can be operated to rotate the inner shaft 500within a lumen of the outer shaft 400 while the distal handle 110 can beheld stationary. The distal handle 110, disposed distally of theproximal handle 112, will also prevent distal axial translation of theinner shaft 500 with respect to the outer shaft 400. A person skilled inthe art will appreciate that the handle assembly 104 can include anyother components that facilitate interaction between the outer shaft 400and inner shaft 500 and that are used to conveniently operate theinserter tool 102 to anchor the sheath and tendon within a bone hole.

In the illustrated embodiment, the handle 110 of the handle assembly 104can be fully cannulated such that it has an inner lumen 412 extendingtherethrough that is coaxial with the inner lumen 403 of the outer shaft400, as shown in FIGS. 4B and 5B. The inner lumen 412 can be configuredto receive therein the proximal portion 500 p of the inner shaft 500. Asshown in FIGS. 5A and 5B, the proximal handle 112 has an inner lumen 512extending at least partially therethrough and coaxial with the lumen 412defined within the distal handle 110. As shown in FIG. 5B, the innerlumens 412, 512 extending through the handle assembly 104 can have thesame or substantially the same diameter. The proximal portion 500 p ofthe inner shaft 500 extends proximally through the inner lumen 412 ofthe distal handle 110 and extends proximally through the inner lumen 512of the proximal handle 112, as also shown in FIG. 5B. While the moredistal portion of the inner shaft's proximal portion 500 p can rotatewithin the distal handle 110, the inner shaft's more proximal portion isfixedly coupled to the proximal handle 112 so that rotation of theproximal handle 112 causes the inner shaft 500 to rotate. Threads orother mating features can be used to mate the proximal portion to theproximal handle.

A person skilled in the art will appreciate that the handle assembly 104can have other suitable configurations that allow rotating the innershaft 500 while preventing distal sliding of the inner shaft 500 withinthe outer shaft 400, as the embodiments described herein are not limitedto a specific mechanism. Furthermore, the handle assembly 104 caninclude features for controlling movement of the inner and outer shaftsrelative to one another. In addition, in embodiments in which aguidewire is used, the handle assembly can also include a feature forengaging the guidewire.

As indicated above, in use, prior to advancing the expander 300 into thesheath 200, the distal end of the expander 300 is partially threadedinto the proximal end of the sheath 200 and the inner shaft 500 extendsthrough both the sheath 200 and expander 300. The sheath 200 can be heldon the inserter tool by friction fit between the inner lumen 206 of thesheath 200 and the drive tip 502 d of the inner shaft 500 extendingthrough the lumen 206. Thus, the sheath 200 is pressed onto the drivetip of the inner shaft 500. A surgeon can thus hold the distal handle110 coupled to the outer shaft 400 so that the distal handle 110 remainsstationary while rotating the proximal handle 112 coupled to the innershaft 500 to thereby rotate the inner shaft 500 within the outer shaft400. Because the proximal handle 112 abuts a proximal surface of thedistal handle 110, the distal handle 110 prevents distal axialtranslation of the inner shaft 500 within the outer shaft 400. In thisway, the inner shaft 500 rotates the expander 300 coupled thereto so asto rotatably insert the expander 300 into the sheath 200.

The system 100 described herein can be used to implant a sheath oranchor in a bone in various different ways. One exemplary method forimplanting an anchor in bone, for example, to perform a biceps tenodesissurgery, is shown in connection with FIG. 6D and also with reference toFIGS. 6A-6C. While the method is described in connection with theexpander 300 and sheath 200, a person skilled in the art will appreciatethat the method can be performed using various anchors and tools, andthat it can be performed for anchoring any tissue to any bone.

In a biceps tenodesis procedure, a biceps tendon is retrieved in asuitable manner and a size of the tendon is determined to allow asurgeon to select an appropriately sized implant and tools. Exemplaryembodiments of methods and devices for determining a size of the tendonand tools to insert and retain the tendon in a bone hole are furtherdescribed in U.S. application Ser. No. 14/610,602 entitled “BicepsTenodesis Implants and Delivery Tools” filed on Jan. 30, 2015, which ishereby incorporated by reference in its entirety. Further, in someembodiments, the inserter tool 102 can be used to size the tendon byusing a distal fork (e.g., fork 401). Tools having different sizes canhave differently sized forks. After properly sizing the tendon, theproper size reamer can be used to ream a bore in the bone, e.g., thehumorous. However, a person skilled in the art will appreciate that thebone hole can be formed using any suitable bone hole preparationtechniques and devices.

The bone hole diameter can be sized to allow the fork 401 having thetendon 600 positioned between the prongs 404, 406 thereof and the sheath200 to be easily inserted therein. The anti-plunge tabs 216 a-216 bprevent over insertion of the sheath into the bone hole. Alternatively,the outer shaft 400 of the inserter tool 102 may have a greater diametercompared to the tunnel 602, so that the outer shaft 400 will beprevented from entering into the bone hole 602. This is shown, forexample, in FIG. 6D.

After a bone hole 602 in bone B is prepared, the sheath 200 coupled to adistal end of the inserter tool 102 can be positioned adjacent to thetendon 600 to be advanced into the bone hole 602. The system 100including the inserter tool 102, the expander 300, and the sheath 200,can be an “all-in-one” device that can be used to first “dunk” thetendon 600 into the bone hole 602 and to then drive the expander 300into the sheath 200 to anchor the sheath 200 in the bone hole. Thus,there may be no need for separate inserter and driver tools as the“all-in-one” device has both of these functionalities. It should beappreciated that, although not shown in connection with the describedembodiments, in some embodiments, a guidewire can be additionally used.

As shown in FIGS. 6A-6D, the inserter tool 102 can have the sheath 200and expander 300 coupled distally thereto such that the expander 300 andthe sheath 200 are disposed over the inner shaft 500. The sheath 200 canheld on the inner shaft 500 by friction-fit or press-fit. Alternativelyor additionally the sheath can be held onto the expander 300 by“pre-threading” the expander 300 into a proximal end of the sheath 200,as shown in FIGS. 6C-6D. The expander 300 in turn is held onto theinserter tool 102. The prongs 404, 406 of the distal fork 401 on theouter shaft 400 extend along the slots in the sheath 200, as shown inFIGS. 6A-6D.

Before it is advanced into the bone hole 602, the inserter tool 102 canbe manipulated to position the tendon 600 between the prongs 404, 406 ofthe fork 401. Once the inserter tool 102 with the sheath 200 andexpander mounted thereon is properly positioned with the tendon 600extending around the sheath 200, the inserter tool 102 can bemanipulated to advance, or dunk, the tendon 600 and sheath 200 into thebone hole 602. The sheath 200 is in an unexpanded configuration duringinsertion and is supported by the prongs 404, 406. As discussed above,the inner shaft 500 can extend through the outer shaft 400 such that thedistal-most end 503 of the inner shaft 500 abuts against a distal innersurface of the sheath 200. Thus, in the illustrated embodiment, theinner shaft 500 of the inserter tool 102 can be used to apply force tothe distal end of the sheath 200 to advance the sheath 200 and thetendon 600 into the bone hole 602. The distal end of the arms on theouter shaft can also apply a distal force to the sheath, however, themajority of the force should be applied to the distal end of the sheathso as to avoid the risk of causing damage to the sheath.

After the inserter tool 102 with the sheath 200 and expander coupledthereto and the tendon 600 are advanced into the bone hole 602, theinserter tool 102 can be manipulated to drive the expander 300 into thesheath 200 to expand the sheath 200 into an expanded configuration tothus anchor it within the bone hole 602. The inner shaft 500 of theinserter tool 102 can be rotated relative to the outer shaft 400 tocause the expander to thread into the sheath. The pre-threadedconfiguration will cause the threads to advance the expander distallywithin the sheath and along the drive tip. For example, referring backto FIGS. 1A and 1B, a surgeon can hold the handle 110 coupled to theouter shaft 400 so that the distal handle 110 remains stationary whilethe proximal handle 112 coupled to the inner shaft 500 is rotated. Axialtranslation of the inner shaft 500 relative to the outer shaft 400 isprevented. At the same time, the outer shaft 400 remains stationary and,because the prongs 404, 406 distally coupled thereto extend into theslots in the sheath 200, the sheath 200 can be anchored while beingprevented from rotating. In this way, the expander 300 will translatedistally into the sheath 200 until the full length or substantially thefull length of the expander 300 is driven into the sheath 200 to therebyexpand the sheath 200 and anchor it within the bone hole 602. Becausethe sheath 200 is prevented from rotating while the expander 300 isadvanced thereto, the possibility of twisting the tendon can beeliminated or reduced, which can reduce a risk of damaging the tendon.

When the distal end of the inserter tool 102 is fully inserted into thebone hole 602, the anti-plunge tabs and the distal end of the outershaft will rest against the bone, and the cortical retaining tabs willextend below the cortical bone. The viewing windows 410 opposite oneanother can facilitate viewing of the expander, and they can receive thetendon 600 so as to allow outer shaft to rest against sheath. When theexpander 300 is fully inserted into the sheath 200, the expander 300will cause the sheath 200 to expand radially outward to engage thetendon 600 between the sheath 200 and the bone hole 602, and to therebyanchor the sheath and tendon within the bone hole. The ribs on the outersurface of the sheath can also engage bone to prevent back-out andtendon slippage. Once the sheath 200 is properly anchored into the bonehole to thereby anchor the tendon, the inserter tool 102 can be removedwhile the sheath 200 remains in the bone hole (not shown).

FIGS. 7A-8D illustrate another exemplary embodiment of a bicepstenodesis system 700 having an inserter or delivery tool 702 thatincludes an outer shaft 1000, an inner shaft 1100, a driver shaft 1200disposed between the outer shaft 1000 and the inner shaft 1100, and aproximal handle assembly 704 coupled to proximal ends of the outer,inner, and driver shafts 1000, 1100, 1200. The outer shaft 1000 and theinner shaft 1100 are configured to advance a sheath 800 into a bonehole, and the driver shaft 1200 is configured to drive an expander 900into the sheath 800. A person skilled in the art will appreciate thatthe implant is shown by way of example only and that the tool can beused with any implant.

In the illustrated embodiment, the inner shaft 1100 can be rigidly fixedto or integrally formed with the outer shaft 1000 and a distal end ofthe inner shaft 1100 can abut against a distal inner surface of thesheath 800 such that the inner shaft 1100 can apply a force to thedistal end of the sheath 800 to advance the sheath 800 into a bone hole.A distal end of the driver shaft 1200 is configured to extend into adrive recess in the expander 900 and to rotate and axially translatewith respect to the outer shaft 1000 to drive the expander 900 into thesheath 800.

The sheath 800 can have a variety of different configurations. In theillustrated exemplary embodiment, the sheath 800 can be configuredsimilar to sheath 200 (FIGS. 1A, 1B, 2A, 2B, and 2C). For example, likesheath 200, sheath 800 has a generally elongate cylindrical shape, witha circular or oval cross-sectional geometry. The sheath 800 has aproximal end 800 p and a distal end 800 d and it can be a split sheath,with first and second sidewalls that are connected at the distal end 800d and that are separated by first and second elongated slots 804 a, 804b extending therebetween, as shown in FIG. 8D. The sheath 800 has aninner lumen 806 defined by the inner surfaces of the first and secondsidewalls and extending at least partially through the sheath 800. Aproximal portion 808 of the sheath 800 can have surface features, suchas ribs 810 (FIGS. 7B and 8D), or any other bone-engaging surfacefeatures (e.g., threads, teeth, or other protrusions). A distal portion812 of the sheath 800 can be free of surface features. However, in someembodiments, the distal portion 812 can include one or more surfacefeatures.

In the illustrated embodiment, the sheath 800 includes internal threadsformed in its lumen 806 on inner facing surfaces of the sheath 800 forthreadably mating with the expander 900. Alternatively, the inner facingsurfaces may be free of threads. The sheath 800 can include otherfeatures similar to those described for sheath 200, or any othersuitable features.

The expander 900 is effective to expand the sheath 800 to anchor thesheath 800 and a tendon coupled thereto within a bone hole. The expander900 can also have a variety of different configurations. In theillustrated embodiment, the expander 900 can be configured similar toexpander 300 (FIGS. 1A, 1B, 3A, 6A, 6B and 6C). Thus, as shown in FIGS.7B and 8B, the expander 900 is in the form of a screw having a generallycylindrical shape with threads 902 formed on the outer surface thereofand extending along the entire length of the expander 900 to facilitateengagement with the sheath 800. The threads 902 can engage the internalthreads formed on inner facing surfaces of the sheath 800 when theexpander 900 is advanced into the sheath 800 to expand it outward.Although the expander 900 is shown as having threads formed thereon, itshould be appreciated that, in some embodiments, the expander 900 can befree of threads and it can be configured, for example, similar toexpander 320 in FIG. 3B or expander 340 in FIG. 3C. Other configurationsof the expander 900 can be used as well. The expander screw 900 cantaper distally inward to a reduced diameter along at least a portion ofthe length thereof. In the illustrated embodiment, the expander 900tapers distally to a reduced diameter at a distal end 900 d thereof.

The expander 900 can be fully cannulated so that it has an inner lumenextending therethrough. The inner lumen can be configured and sized tofit a drive tip of the driver shaft 1200. For example, the inner lumenof the expander 900 can have a hexagonal cross-section so that it canreceive a hexagonal drive tip of the driver shaft 1200. The drive tip ofthe driver shaft 1200 can extend partially or fully through the innerlumen of the expander 900. However, one skilled in the art willappreciate that the inner lumen of the expander screw 900 can have anyother suitable configuration, as embodiments are not limited in thisrespect. For example, in embodiments in which the expander is apush-type expander that is pushed into the sheath rather than rotatablytranslated thereinto, a drive feature to rotatably advance expander 900may not be required and the inner lumen of the expander screw 900 can becylindrical.

As shown in FIGS. 7A, 7B, and 8B-8D, the expander screw 900 canremovably mate to a distal end of the driver shaft 1200, e.g., bysnap-fit, press-fit, or using other suitable technique(s). In this way,the expander screw 900 can translate and, in some embodiments, rotatetogether with the driver shaft 1200. Thus, unlike the embodiment ofsystem 100 (FIGS. 1A and 1B) where the expander 300 is pre-threaded intothe sheath in a loading stage (before the sheath 200 is expanded withina bone hole), in the embodiment of system 700 the expander screw 900need not be pre-coupled to the sheath 800 before the inserter tool 702is manipulated to insert the expander screw 900 into the sheath 800. Anadvantage of such a configuration can be that certain design constrainson the expander and the sheath can be eliminated.

The outer shaft 1000 of the tool can have various configurations. Forexample, the outer shaft 1000 can be similar to outer shaft 400 (FIGS.1A, 1B, and 4A). Thus, the outer shaft 1000 can have a generallyelongate cylindrical shape and can define an inner lumen 1007 extendingtherethrough between proximal and distal ends 1000 p, 1000 d thereof.The inner lumen 1007 can slidably and rotatably receive therein thedriver shaft 1200, as shown in FIGS. 7A, 7D, 8A, and 8B.

Similar to outer shaft 400, outer shaft 1000 can have a fork 1001extending distally from the distal end 1000 d thereof, as shown in FIGS.7A, 7B, 7C, and 7D. The fork 1001 of the outer shaft 1000 includesopposed distal first and second prongs 1004, 1006 that can be similar tofirst and second prongs 404, 406 coupled to outer shaft 400. Thus, thefirst and second prongs 1004, 1006 can be fixedly coupled to a distalportion 1002 d of the outer shaft 1000, e.g., by fixedly mating withrespective bores extending longitudinally through arms of the distalportion 1002 d. Alternatively, the first and second prongs 1004, 1006can be integrally formed with the outer shaft 1000. The prongs 1004,1006 can be configured to extend along the slots 804 a, 804 b in thesheath 800 so as to align a tendon with the sheath 800 and, inembodiments in which the driver shaft 1200 is rotated to insert theexpander 900 into the sheath 800, prevent rotation of the sheath 800.

The inner shaft 1100 can also have various configurations. As shown inFIG. 7B, the inner shaft 1100 has a generally elongate cylindricalshape. A distal end 1100 d of the inner shaft 1100 can be configured toapply a force to a distal end of the sheath 800 (e.g., a distal innersurface of the sheath 800) to advance the sheath 800 and a ligament intothe bone hole. A proximal end 1100 p of the inner shaft 1100 can befixedly coupled to the outer shaft 1000 via the proximal handle assembly704, as discussed in more detail below. The inner shaft 1100 can haveany suitable size so that it can fit within an inner lumen of the drivershaft 1200 that is, in turn, disposed within the outer shaft 1000. Thus,a diameter of the inner shaft 1100 is less than a diameter of the innerlumen 1203 of the driver shaft 1200.

As shown in FIG. 7D, the inner shaft 1100 has a length such that thedistal-most end terminates at a location distal to the distal end 1000 dof the outer shaft 1000 and proximal to a distal-most end of the firstand second prongs 1004, 1006. Also, as shown in FIGS. 7D and 7E, theinner shaft 1100 extends through the entire length of the driver shaft1200 so that the distal end 1100 d of the inner shaft 1100 extendsdistally beyond the distal end 1200 d of the driver shaft 1200 and theproximal end 1100 p of the inner shaft 1100 extends proximally beyondthe proximal end 1200 p of the driver shaft 1200.

The driver shaft 1200 disposed between the outer shaft 1000 and theinner shaft 1100 can have a variety of configurations. The driver shaft1200 can be fully cannulated so that it has an inner lumen 1203extending therethrough. As mentioned above, the lumen 1203 is configuredto receive the inner shaft 1100 therein. As shown in FIGS. 7B and 7E,the driver shaft 1200 can have a generally elongate cylindrical shapeand it can have an inner lumen with an inner diameter greater than anouter diameter of the inner shaft 1100, and an outer diameter of thedriver shaft can be less than an inner diameter of the outer shaft 1000.

In the embodiment illustrated in FIG. 7B, the driver shaft 1200 has theexpander 900 coupled to the distal end 1200 d thereof. The distal end1200 d of the driver shaft 1200 can have one or more retaining featuresconfigured to removably retain the expander 900 thereon. For example,the distal end 1200 d can have retaining tabs or protrusions 1206extending distally therefrom and configured to hold the proximal end ofthe expander 900 on the driver shaft 1200. In the illustratedembodiment, the driver shaft 1200 has two retaining tabs 1206 a, 1206 b(FIG. 7E) configured to retain the expander 900 by a friction fit,snap-fit, or in any other manner. Any suitable number of any retainingfeatures can be used to removably mate the expander 900 so that theexpander 900 can be distally translated or both translated and rotatedtogether with the driver shaft 1200. The retaining features can beintegrally and/or monolithically formed with driver shaft 1200, or theycan be fixedly attached to the driver shaft 1200.

It should be appreciated that the expander 900 can be coupled to thedistal end of the driver shaft 1200 without the use of any retainingfeatures. For example, the drive shaft can include a drive tip formed onthe distal end thereof and configured to extend into and frictionallyengage with a bore in the expander 900. The tip can be configured as ahexagonal or other similar-shaped tip to allow the driver shaft 1200 torotate the expander 900 into the sheath.

Referring back to FIGS. 7A and 7B, the handle assembly 704 can include abody 710 coupled to the proximal end 1000 p of the outer shaft 1000, afirst handle 712 coupled to the proximal end 1100 p of the inner shaft1100, and a second handle 714 coupled to the proximal end 1200 p of thedriver shaft 1200. It should be appreciated that the handles 712, 714are referred to as “first” and “second” for description purposes onlyand not to indicate any specific order of assembly or operation of thesecomponents. The first and second handles 712, 714 can be coupled to thebody 710 in any suitable manner, as embodiments are not limited in thisrespect. As shown in FIG. 7A, the handle assembly 704 can be configuredas a single handle component that can be used to operate the outer,driver, and inner shafts 1000, 1200, 1100.

One skilled in the art will appreciate that the handle assembly 704 caninclude any other suitable components not shown herein. Furthermore, oneskilled in the art will appreciate that the handle assembly 704 is shownby way of example only, as any other handle assembly can be used tooperate the inserter tool 702.

As shown in FIG. 7C, the body 710 of the handle assembly 704 isgenerally cylindrical and includes proximal and distal portions 716, 718coupled via opposed arms or sidewalls 720 a, 720 b extendinglongitudinally therebetween. The proximal and distal portions 716, 718can be fully cannulated such that they define lumens 1005, 1007extending therethrough, respectively. The lumen 1005 in the proximalportion 716 can have a greater diameter than a diameter of the lumen1007 in the distal portion 718, as shown in FIGS. 7B and 7C.

The arms 720 a, 720 b extend rigidly between the portioned and distalportions 716, 718 so as to define a space between the proximal anddistal portions 716, 718. The space is preferably sufficient to allowaccess to the handle 714 and to also allow distal translation of thehandle 714 to drive the expander 900 into the sheath 800. The space hasa height substantially equal to or greater than a length of the expandersuch that movement of the handle from a proximal position to a distalposition can advance the full length of the expander into the sheath.

As shown in FIGS. 7A-7D, the proximal portion 716 of the body 710 can bein the form of a hollow cylinder. As shown in FIGS. 7A and 7D, the firsthandle 712 coupled to the proximal end of the inner shaft 1100 can bedisposed entirely within the lumen 1005 in the proximal portion 716. Thehandle 712 can be fixedly coupled within the lumen 1005 in any suitablemanner, for example, by threads, press-fitting, snap-fitting, or usingany other coupling techniques.

In the illustrated embodiment, the distal portion 718 of the body isshaped as a disk. The inner lumen 1007 extends through the distalportion 718 and is configured to slidably and rotatably receive thereinthe driver shaft 1200. As shown in FIGS. 7A and 7D, the driver shaft1200 can be disposed within the lumen 1007 so that the proximal end ofthe driver shaft 1200 extends proximally beyond a proximal facingsurface 719 of the distal portion 718 and the second handle 714 coupledto the driver shaft 1200 is disposed just proximal of the proximalfacing surface 719. As shown in FIGS. 7A and 7D, the second handle 714can be disposed between the arms 720 a, 720 b such that it can berotated and translated within the space defined by the arms 720 a, 720 bof the handle assembly 704.

As shown in FIGS. 7A, 7B, 7D, and 7F, the second handle 714 is fixedlycoupled to the proximal end of the driver shaft 1200. The illustratedhandle 714 is substantial disc-shaped, however, it can variousconfigurations. The handle 714 is fully cannulated such that the innerlumen 1203 extending through the driver shaft 1200 extends through thesecond handle 714 as well. Such a configuration allows the driver shaft1200 and the handle 714 to be slidably disposed on the inner shaft 1100,as shown in FIGS. 7A, 7D, and 7E.

The system 700 of FIGS. 7A-7E can be used to implant a sheath or anchorin a bone in various different ways. One exemplary method for implantingan anchor in bone, for example, to perform a biceps tenodesis surgery,is shown in connection with FIGS. 8C, 8D, 9A and 9B. A person of skillin the art will understand that the implant described herein is shown byway of example only, as the illustrated tool can be used with anysuitable implant. The method can include retrieving a biceps tendon1300, determining a size of the tendon, and preparing a bone hole 1302in bone B similarly to as discussed above in connection with FIG. 6Dand/or using any other suitable techniques. Similar to system 100 ofFIGS. 1A and 1B, system 700 can be an “all-in-one” device that can usedto first “dunk” the tendon 1300 into the bone hole 1302 and to thendrive the expander 900 into the sheath 800 to thereby anchor the sheath800 and the tendon 1300 in the bone hole. It should be appreciated that,although not shown in connection with the described embodiments, in someembodiments, a guidewire can additionally be used.

In the illustrated embodiment, as shown in FIG. 8C, prior to advancingthe expander 900 into the sheath 800, the expander 900 can be coupled tothe driver 1200 of the inserter tool 702 such that the expander 900 isproximal of the sheath 800. As a result, the expander and the drivershaft can slide freely relative to the sheath and the outer and innershafts Like in the system 100 (FIG. 1A), the prongs 1004, 1006 of thedistal fork on the outer shaft 1000 extend along the slots in the sheath800. FIGS. 8D, 9A, and 9B illustrate the inserter tool 702 having thesheath 800 and expander 900 coupled thereto such that the expander 900and the sheath 800 are disposed over the inner shaft 1100.

Before the sheath is advanced into the bone hole 1302, the inserter tool702 can be manipulated to position the tendon 1300 between the prongs1004, 1006 of the fork 1001. The inserter tool 702 can be manipulated toadvance, or dunk, the tendon 1300 into the bone hole 1302. Advancementof the inserter tool 702 will cause the distal end of the inner shaft1100 to abut against a distal inner surface of the sheath 800 andthereby apply force to the distal end of the sheath 800 to advance thesheath 800 and the tendon 1300 into the bone hole 1302. The distal endof the outer shaft can apply a distal force to the sheath, however, themajority of the force is applied to the distal end of the sheath so asto avoid the risk of causing damage to the sheath.

After the inserter tool 702 is used to advance the sheath 800 and thetendon 1300 into the bone hole 1302, the inserter tool 702 can bemanipulated to drive the expander 900 into the sheath 800 to expand thesheath 800 and thus anchor it within the bone hole 1302. In theillustrated embodiment, force can be applied to the driver shaft 1200 ofthe inserter tool 702 to cause the expander 900 removably coupledthereto to advance into the sheath 800. The driver shaft 1200 cantranslated distally (e.g., by operating handle 714 shown in FIG. 7A)relative to the outer shaft 1000 to cause the expander 900 to be pushedinto the sheath 800 to thus expand the sheath 800 outward. Inparticular, the handle is moved from an initial proximal-most positionwithin the same space in the body to a final distal-most position, inwhich the handle contacts and abuts against the proximal surface of thedistal portion of the body. If the expander includes threads, the drivershaft can additionally be rotated to thread the expander into thesheath. At the same time, the outer shaft 1000 remains stationary as theprongs 1004, 1006 coupled thereto extend into the slots in the sheath800 prevent the sheath 800 from rotating. Thus, the possibility oftwisting the tendon can be eliminated or reduced, which can reduce arisk of damaging the tendon.

When the expander 900 is fully inserted into the sheath 800, theexpander 900 will cause the sheath 800 to expand radially outward toengage the tendon 1300 between the sheath 800 and the bone hole 1302,and to thereby anchor the sheath and tendon within the bone hole. Theribs on the outer surface of the sheath can engage bone to preventback-out. The cortical retaining tabs and/or any other portions of thesheath can also help retain the sheath within the bone hole. Once thesheath 800 is properly anchored into the bone hole to thereby anchor thetendon, the inserter tool 702 can be removed (not shown). Optionally,the engagement between the inner shaft and the expander can be releasedby pulling the outer shaft 1000 proximally while holding the drive shaftto prevent the sheath and expander from being pulled out of the bonehole.

FIGS. 10A-10B illustrate another embodiment of an inserter tool 1400 forsimultaneously delivering a sheath 1510 and an expander 1520 into a bonehole. In this embodiment, the tool 1400 has a handle 1410 with a singleshaft 1420 extending distally from the handle 1410 that is used to bothpush the sheath 1510 into a bone hole with the expander 1520 trailingbehind the sheath 1510, and to rotate and drive the expander 1520distally into the sheath 1510 to thereby anchor the sheath 1510 withinthe bone hole. The illustrated implant, which includes the sheath 1510and the expander 1520, is described in more detail in U.S. patentapplication Ser. No. 14/610,602 filed on Jan. 30, 2015, and in U.S.patent application Ser. No. 14/610,626 filed on Jan. 30, 2015, which arehereby incorporated by reference in their entireties. A person skilledin the art will appreciate that the implant is shown for illustrationpurposes only, and that the inserter tool 1400 can be used with variousimplants.

As shown in FIG. 10A, the handle 1410 of the tool has a generallyelongate cylindrical configuration to facilitate grasping. A personskilled in the art will appreciate that the handle 1410 can have anyshape suitable for grasping. While not shown, the handle has a lumenextending therethrough and can include features therein for releasablyengaging a proximal end of a guidewire, as disclosed in U.S. patentapplication Ser. No. 14/610,602 filed on Jan. 30, 2015, which is herebyincorporated by reference in its entirety. The handle can also include abore formed in the distal end thereof for receiving a proximal end ofthe shaft 1420 to allow the handle 1410 and the shaft 1420 to be fixedlymated to one another.

The shaft 1420 of the tool 1400 can also have a variety ofconfigurations. In the illustrated embodiment, the shaft 1420 has agenerally elongate shape with a proximal end 1420 p that is mated to thehandle 1410. As shown in more detail in FIG. 10B, the shaft 1420 has adistal end in the form of a drive tip 1420 d with a reduced diametersuch that the drive tip 1420 d can extend into and mate with theexpander 1520. The shape of the drive tip can vary, but preferably thedrive tip 1420 d has a shape, such as a hexagonal shape, that allows arotational force to be applied by the drive tip 1420 d to the expanderto cause the expander 1520 to rotate. The length of the drive tip 1420 dcan also vary, but the length is preferably sufficient to allow thedrive tip 1420 d to extend through a substantial or entire length of adrive socket 1520 s formed in the expander 1520.

As further shown in FIG. 10B, the shaft 1420 includes a lumen extendingentirely therethrough. The lumen is configured to receive an innershaft, rod or a guidewire 1430 that extends between the guidewireengaging feature (not shown) in the handle 1410 and the sheath 1510. Theguidewire 1430 and the mating connection between both the handle 1410and the sheath 1510 are described in more detail in the aforementionedapplications, but in general the guidewire 1430 has a distal tip 1430 tthat is configured to releasably mate, e.g., by threads or other matingfeatures, a blind bore formed in a distal end of the sheath 1510. Sincethe proximal end of the guidewire 1430 is held within the handle 1410,as indicated above, the guidewire 1430 will function to retain thesheath 1510 on the tool 1400.

In use, when the device is fully assembled, the expander 1520 ispositioned over the drive tip 1420 d on the shaft 1420, which in turn ispositioned over the guidewire 1430. The sheath 1510 is mated to thedistal end of the guidewire 1430, and the proximal end of the guidewire1430 is mated within the handle 1410 to thereby retain the sheath 1510and the expander 1520 on the distal end of the tool 1400. In anexemplary embodiment, as shown, the expander 1520 is at least partiallythreaded into the sheath 1510 such that rotation of the expander 1520will cause the expander 1520 to thread distally into the sheath 1510.

The tool 1400 can be used to anchor tissue within a bone hole inaccordance with the methods described above and described in theaforementioned applications. In particular, the tool 1400 can bemanipulated to advance the sheath 1510 and a tendon positioned betweenthe forks on the distal end of the sheath, into a bone hole. When thehandle 1410 is pushed distally, the force will be transferred throughthe guidewire 1430 to cause the distal end of the guidewire 1430 to pushthe sheath 1510 into the bone hole. Once the sheath 1510 is fullyinserted into the bone hole, e.g., when the tabs at the proximal end ofthe sheath 1510 abut against the bone surface, the translationalcoupling between the guidewire 1430 and the tool 1400 can be disengagedand the tool 1400 can be rotated to thereby rotate the expander 1520.The threads on the expander 1520 will thereby drive the expander intothe sheath 1510 to expand the sheath outward and thereby anchor thetendon within the bone hole. In an exemplary embodiment, the matingfeature inside the handle 1410 allows the tool 1400 to rotate withoutcausing corresponding rotation of the guidewire 1430, and thus withoutcausing rotation of the sheath 1510.

A person skilled in the art will appreciate that the biceps tenodesismethods and devices disclosed herein can be used in a variety ofsurgical procedures to prevent trauma or damage to a tendon beingattached to a bone via a bone hole. The present invention also hasapplication in conventional joint repair surgeries.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A bone anchor inserter tool, comprising: an outershaft having proximal and distal ends and an inner lumen extending atleast partially therethrough, the distal end having first and secondprongs extending distally therefrom; and an inner shaft extendingthrough the inner lumen of the outer shaft and being non-slidably fixedto the outer shaft, the inner shaft having a distal-most end terminatingat a location distal to the distal end of the outer shaft and proximalto a distal-most end of the first and second prongs.
 2. The tool ofclaim 1, wherein the inner shaft is freely rotatable relative to theouter shaft.
 3. The tool of claim 1, wherein a distal portion of theinner shaft is in the form of a drive tip that is configured to extendinto a lumen in an implant and to apply a rotational force to theimplant.
 4. The tool of claim 1, wherein the first and second prongscomprise elongate wires, each elongate wire having a proximal end thatis fixedly disposed within a bore formed in the distal end of the outershaft.
 5. The tool of claim 1, wherein the first and second prongscomprise elongate members formed from a super elastic material.
 6. Thetool of claim 1, wherein the distal end of the outer shaft includesviewing windows formed in opposed sidewalls thereof.
 7. The tool ofclaim 1, wherein the inner shaft is non-rotatably fixed to the outershaft.
 8. The tool of claim 1, further comprising a driver shaft havingan inner lumen extending therethrough, the driver shaft being configuredto be slidably and rotatably disposed between the outer shaft and theinner shaft.
 9. The tool of claim 8, wherein the driver shaft includes adrive tip at a distal end thereof that is configured to extend into alumen in an implant and to apply a rotational force to the implant. 10.A bone anchor and delivery system, comprising: an anchor assemblyincluding an expandable sheath having opposed slots formed therein andan inner lumen extending at least partially therethrough, and anexpander configured to be received within the inner lumen of the sheathto cause the sheath to expand outward, the expander having an innerlumen extending therethrough; and a delivery tool including an outershaft having first and second prongs extending distally from a distalend thereof and configured to extend along opposed slots formed in thesheath, and an inner shaft extending through and mated to the outershaft such that the inner shaft is prevented from sliding axiallyrelative to the outer shaft; wherein, when the prongs of the outer shaftare positioned to extend along the opposed slots in the sheath and theexpander is disposed within the outer shaft proximal of the sheath, theinner shaft extends through the inner lumen in the expander and a distalend of the inner shaft abuts against a distal inner surface of thesheath such that the inner shaft can apply a force to the sheath toadvance the sheath into a bone hole.
 11. The system of claim 10, whereinthe inner shaft is freely rotatable relative to the outer shaft.
 12. Thesystem of claim 10, wherein the inner shaft is non-rotatably fixed tothe outer shaft.
 13. The system of claim 10, further comprising a drivershaft having an inner lumen extending therethrough, the driver shaftbeing slidably and rotatably disposed within the outer shaft, and theinner shaft being disposed through the inner lumen of the driver shaft.14. The tool of claim 13, wherein the driver shaft includes a drive tipat a distal end thereof that is configured to extend into a drive recessin the expander for driving the expander into the sheath.
 15. A methodof implanting an anchor in bone, comprising: positioning a sheathcoupled to a distal end of an outer shaft of an inserter tool adjacentto a ligament to be advanced into a bone hole; manipulating the insertertool to advance the sheath and the ligament into the bone hole, theinserter tool having an inner shaft extending through the outer shaft,the inner shaft applying a force to a distal end of the sheath toadvance the sheath and the ligament into the bone hole; and manipulatingthe inserter tool to advance an expander disposed over the inner shaftinto the sheath, the expander causing the sheath to expand outward andengage the bone hole to thereby anchor the ligament within the bonehole.
 16. The method of claim 15, wherein manipulating the inserter toolto advance the expander into the sheath comprises rotating the innershaft relative to the outer shaft to cause the expander to be threadedinto the sheath.
 17. The method of claim 16, wherein the inner shaft isprevented from translating relative to the outer shaft.
 18. The methodof claim 16, wherein the expander is at least partially threaded intothe sheath when the sheath is advanced into the bone hole.
 19. Themethod of claim 15, wherein manipulating the inserter tool to advancethe expander into the sheath comprises axially translating a drivershaft within the outer shaft and over the inner shaft.
 20. A method foranchoring tissue to bone, comprising: manipulating an inserter tool toadvance a sheath coupled to a distal end of the inserter tool and toadvance a tendon positioned around the sheath, into a bone hole, theinserter tool having a handle with a drive shaft extending distally fromthe handle, and the inserter tool having an expander positioned proximalof the sheath and disposed on a distal end of the drive shaft such thatthe expander trails the sheath as the sheath and the tendon are advancedinto the bone hole; and rotating the handle of the inserter tool torotate the drive shaft and thereby cause the expander to rotate, whereinthreads on the expander engage corresponding threads formed within thesheath to advance the expander distally into the sheath, the expandercausing the sheath to expand outward to thereby anchor the sheath andthe tendon within the bone hole.